Protecting Research Participants

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Protecting Research Participants A Time for
Change National Bioethics Advisory Commission
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PRELIMINARY POINTS I

• Therapy df. A class of activities designed
  solely to benefit an individual or the members of
  a group. It may take several forms treatment
  of a disease diagnostic procedures or
  preventative measures.
• Research df. A class of scientific activities
  designed to develop or contribute to
  generalizable knowledge.
• The general justification for human research is
  that a human organism responds to biomedical
  interventions or other stimuli in ways that could
  not be predicted on the basis of studies with
  human or nonhuman animals.

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TWO KINDS OF RESEARCH

• Clinical research df. Research that is
  combined with the diagnosis, treatment, or
  prevention in the research subjects
  themselves. It is research aimed directly
  toward discovering better methods of diagnosing
  or treating the condition from which human or
  animal patients are suffering or toward
  preventing disease in susceptible humans or
  animals. For instance, when a polio vaccine is
  tested on subjects susceptible to polio.
• Nonclinical research df. Research that is
  unrelated or not directly related to an illness
  or susceptibility of the subjects involved in
  the research. For instance, a drug is tested
  on healthy subjects to see how long it remains in
  the system.

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TWO ESSENTIAL PROTECTIONS

• The National Bioethics Advisory Commission (NBAC)
  identifies two essential protections for human
  participants in medical research
• 1. Independent review of research to assess
  risks and potential benefits of research.
• 2. The opportunity for people to voluntarily
  and knowledgeably decide whether to participate
  in a particular research protocol a protocol
  here is a detailed plan of a medical experiment,
  treatment, or procedure.

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RESPECTING RESEARCH PARTICIPANTS

• NBAC People should participate in research only
  when the study addresses important questions, its
  risks are justifiable, and an individuals
  participation is voluntary and informed.
• NBAC Research must respect the autonomy of
  participants, must be fair in both conception and
  implementation, and must maximize potential
  benefits while minimizing potential harms.

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INDEPENDENT REVIEW

• NBAC No one should participate in research
  unless independent review concludes that the
  risks are reasonable in relation to the potential
  benefits.
• The Institutional Review Board (IRB) is primarily
  responsible for independent review of medical
  research in the US.
• Independent review improves the likelihood that
  decisions are made free from inappropriate
  influences that could distort the central task of
  evaluating risks and potential benefits.
• Independent reviewers should not have a financial
  interest in the research being reviewed.

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LIMITATION OF RISKS

• The NBAC says that there should be some
  limitation on the amount of social and physical
  risk that can be imposed, regardless of the
  participants willingness to participate or the
  monetary (or other) enticement being offered.
• The Commission also says that the possibility of
  some benefit from one element of a study should
  not be used to justify otherwise unacceptable
  elements of research whose potential benefits, if
  any, accrue solely to society at large.
• If aspects of a study present unacceptable
  risks, protocols should not be approved until
  these elements are eliminated.

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IRBs AND BENEFITS AND RISKS

• IRBs (Institutional Review Boards) are key to the
  overseeing of medical research and to determining
  how to assess potential benefits and risks of
  such research, and how to maximize benefits and
  minimize risks.
• One problem is that the nature of research
  changes constantly, and so notions of what
  constitutes acceptable risks and potential
  benefits can be challenged by the changing nature
  of that research.

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VOLUNTARY INFORMED CONSENT

• For the participation of a subject in medical
  research to be appropriate the subject must be
  informed about the nature of the research in
  which he or she will participate, and so the
  nature of any potential risks to and benefits for
  the subject that participation in the research
  may involve.
• For the participation of a subject in medical
  research to be appropriate the subjects
  participation must be fully voluntary as the
  freely made decision to participate is informed
  by the nature of the research.

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VULNERABILITY AND INCLUSIVE RESEARCH I

• NBAC Vulnerable individuals need additional
  protection in research . . . but should not be
  arbitrarily excluded from research for this
  reason alone.
• NBAC The response, whenever possible, should
  not be to exclude people from research, but to
  change the design of the research so that it does
  not create situations in which people are
  unnecessarily harmed.
• The reason not to exclude certain people from
  research is that, if they are excluded, then the
  results of the research may not apply to
  everyone, and may only help part of the
  population.

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VULNERABILITY AND INCLUSIVE RESEARCH II

• A person may be vulnerable because of intrinsic
  characteristics of the person. For instance,
  children or those with certain mental or
  developmental disorders.
• A person may be vulnerable because of his or her
  circumstances. For instance, a person who is
  institutionalized or a woman with small children.
• A vulnerable person of any kind must not be
  exploited by medical researchers.

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VULNERABILITY AND INCLUSIVE RESEARCH III

• NBAC Research participants must be treated
  equally and with respect.
• Research then should be designed, if possible,
  to encourage the participation of all groups
  while protecting their rights and welfare.
• NBAC Ethical research does not avoid
  complexity. Rather, it acknowledges the full
  range and realities of the human condition.

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COMPENSATING FOR HARMS

• Justice requires that any subjects who are harmed
  in medical research be cared for and compensated.
• The fact that a person who is harmed freely chose
  to participate in the research does nothing to
  affect the need to care for and compensate that
  person.
• NBAC It should always be remembered that it is
  a privilege for any researcher to involve human
  participants in his or her research.

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RESPONSIBLE OVERSIGHT I

• The NBAC says that, to be both effective and
  comprehensive, an oversight system must cover
  both federally sponsored and privately sponsored
  research.
• NBAC Participants should be protected from
  avoidable harm, whether the research is publicly
  or privately funded.
• Responsible oversight of private research should
  cover both domestic and international research.

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RESPONSIBLE OVERSIGHT II

• The NBAC says that, in spite of differences
  between government agencies, universities, and
  private companies, there should be uniform
  protections for medical research participants.
• This does not mean, however, that research
  protections should be so rigid that cannot be
  applied in widely different research settings or
  to emerging areas of research.

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RESEARCH RESPONSIBILITY AND EDUCATION

• NBAC the ethical obligation to protect
  participants lies first with researchers, their
  sponsors, and the IRBs that review their
  research.
• NBAC merely adhering to a set of rules and
  regulations does not fulfill the duty of
  researchers to protect participants in research.
  Rather, it is accomplished by acting within a
  culture of concern and respect for research
  participants.
• NBAC Education is the foundation of the
  oversight system and is essential to protecting
  research participants.